MDR Article 22 applicability - Legal manufacturer

#1
Hello,

I was hoping if you can help me come to a resolution on a question I have been pondering for some months.

We are a legal manufacturer of a Class III and a Class IIb (MDR) medical devices. Both are required to work together to ensure the intended purpose is met, and we as the legal manufacturer have designed and validated the products to work together. The Class III has multiple reuses and the Class IIb is a consumable part. Both have separate CE marks, conformity assessments and DOCs.

Both products have their own UDIs, one part must be always placed on the market with the consumable and the consumable can be sold on its own.

Where I keep pondering is does Article 22 actually apply to us as the legal manufacturer (LM).

My current assessment is no, for these reasons;
1. Products have been designed and validated to work together by LM​
2. All packaging and labelling etc dictates that both products are required to be used for the 'system' to meet its intended use​
3. Both products already have their UDIs, and we wouldn't be able to apply two Basic UDI-DI to the same single UDIs​
4. It doesn't seem right that the LM would need a SRN for the legal manufacturing activity plus system producer (terminology from MDCG 2018-3, Oct-2018)​
5. I read a good position statement online that referred back to a ruling by a German regional council looking at a similar situation in Germany, where they didn't have to prepare the combination statement (MDD Art 12) because the products have already undergone conformity assessment by the NB. Thus they consider the declaration as the party for assembly of the system necessary only if they are not the legal manufacturer.​
What I am trying to avoid is putting another UDI on the box in which the product is supplied to the customer in.

Does anybody have experience with Article 22? or agreement/disagreement with my assessment above.
Really appreciate any help,
Alice
 
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dgrainger

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#6
Hi,
It isn't clear if someone is placing the devices on the market as a 'system/procedure pack' nor if it is you or someone else doing this. Could you clarify?
 
#7
Hi,
It isn't clear if someone is placing the devices on the market as a 'system/procedure pack' nor if it is you or someone else doing this. Could you clarify?
Hi dgrainger, we the legal manufacturer are putting both parts on the market, currently not as a system or PP, but I am trying to understand if it should be a system. I hope that clarifies :)
 
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